Plants have been, and continue to be, the primary source of a wide variety of medicinal compounds. For centuries, various forms of botanically derived materials have been used to treat countless different ailments. The botanical materials have typically been in the form of powders made from one or more plants or plant parts or extracts derived from whole plants or selected plant parts. These powders and extracts are, for the most part, complex mixtures of both biologically active and biologically inactive compounds.
In modern day, herbal medicine, although gaining some acceptance in Western society, still faces several specific challenges. First, in the opinion of many highly trained medical practitioners, there is the view that herbal medicine lacks sufficient scientific support data in our highly technical and science oriented society. Secondly, there is concern about which components of an herbal remedy are pharmaceutically effective. Furthermore, the question arises as to the concentrations or dosages present of such pharmaceutically effective components of herbal remedies. In short, traditional medical practitioners are concerned with a lack of both qualitative and quantitative standards for herbal medications. Such a lack of standardization is viewed as hindering the ability to prescribe and adjust dosages of such nontraditional or herbal medications. The lack of such standardization has also lead to a reluctance on the part of regulatory agencies in funding further investigation and acceptance of such nontraditional medications.
Although not meeting some of the criteria of Western traditional medicine, such herbal compositions are known to be quite effective in treatment of a variety of maladies with little or no side effects. In part, the pharmaceutical activity in many instances is attributable not only to the presence of specific biologically active compounds but also to a synergistic effect resulting from the combination of two or more chemical components present in the herbal mixture.
Since herbal treatments, defined as both herbal medications and biologically enhancing herbal compositions, are derived from plants, the chemical composition of such herbal treatments varies according to a number of factors, not the least of which are the genetic composition and growing conditions in which the plant is produced as well as the harvest conditions and isolation of the active components of the plant.
Accordingly, biological variants of a particular plant may typically be expected to produce significant variations in quantities of particular chemical components found in the plant. Likewise, even in the same biological variant of a plant, differences in soil, moisture and other growing conditions may significantly affect the quantities of specific chemical components produced by the plant.
The vast majority of the raw material used to produce botanical products is currently collected form the wild. Wild collected plants are, by definition, produced outside of a controlled environment. This has presented a unique problem for manufacturers of botanical products desiring the control, reproducibility, and standardization that are required of pharmaceuticals. This problem is due primarily to the plurality of components contained in an herbal medicine and the large variation in composition and potency due to the growing, harvesting and processing conditions. Therefore it is desirable to standardize these growing conditions to the extent possible.
Finally, the manner in which a plant is processed can drastically influence the relative proportions and total amounts of specific chemical components isolated from the plant. Thus, such steps as harvesting, storage, reduction in particle size, expression of liquid components and extraction all determine the proportions and amounts of chemical components and hence the pharmaceutical activity of the isolated product.
Considering the many factors which influence the composition and pharmaceutical activity of herbal compositions, it is desirable to employ methods which result in the standardization of herbal compositions both with respect to the chemical compositions thereof and the pharmaceutical activity of such chemical mixtures. In addition, it is desirable to standardize the processing conditions in order to obtain such standardized herbal compositions. Furthermore, being able to accurately determine and compare the compositions of biological mixtures, particularly plant or herbal mixtures, would allow processing conditions to be controlled to obtain reliable pharmacological activity. With such methods available to the scientific community, not only would physicians be able to prescribe specified dosages of herbal compositions with confidence, but herbal composition “manufacturers” would achieve predictable pharmaceutical activity of such mixtures, improved quality control and the ability to differentiate herbal mixtures from varying sources.
Pharmaceutical grade botanical products are advantageous in that they allow careful tracking of the effects of individual compounds, in treatment protocols. Further, the dosage of the drug can be carefully controlled to provide relatively predictable medicinal action. The potential benefit provided by the use of herbal product as medicine is believed by many industry experts to be outweighed by the clinical risks associated with the absence of standard levels of biologically active materials from natural plants. In that respect, herbal products are not well characterized or controlled in a clinical setting.
The present invention is a significant advancement in the field of making herbal extracts for medicinal purposes, providing precise levels of both berberine and hydrastine while at the same time maintaining USDA National Organic Program (NOP) organic certification. The invention offers tremendous benefits since the extract is standardized to biological activity rather than just a chemical marker. This allows for the use of exact quantities of the extract necessary to produce the desired pharmacological activity instead of potentially toxic high doses or ineffective low doses produced by current methods. The invention also permits the manipulation and/or removal of certain pharmacologically active compounds from the extract thereby allowing more precise calculation of the contribution of each compound's activity to that of the whole and permits various ratios of the compounds in the final product based on the results of certain bioassays. In addition, pre-standardization by cultivation and harvesting practices results in higher concentrations of pharmacologically active compounds in the raw material which translates into reduced processing to produce a given amount of extract. Maintenance of USDA NOP certification throughout the production process provides third party certification that the product has been produced in a sustainable manner, important due to many medicinal plant's endangered status, and that no potentially toxic materials such as herbicides, pesticides, or artificial fertilizers have been used.
In one object of this invention, a method was developed for standardizing the levels of biologically active materials from natural plants including, but not limited to, herbal plants. In a more preferable object of this invention, the method is suitable for producing pharmaceutical grade natural products standardized to a specific level of bio-activity from Hydrastis canadensis Linn. (goldenseal) and other berberine and/or hydrastine containing plants. In a preferable object of this invention, the method disclosed is suitable for the precise standardization of marker compounds generally recognized as indicators for the quality of goldenseal. In a more preferable object of this invention, the marker compounds are berberine and hydrastine.